COVID-19 (Coronavirus Disease 2019)NCT06223945

Thrombohemorrhagic Complications of COVID-19

A study testing Prevention algorithm in people with COVID-19 (Coronavirus Disease 2019), run by Volgograd State Medical University at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The nature of the planned study: The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: COVID-19 (Coronavirus Disease 2019)
What is being tested?: Prevention algorithm
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteRussia
Study dates: 12 Jan 2024to 12 Jan 2029
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with thrombohemorrhagic complications who were treated in a covid hospital

Who cannot join

Cancer patients
Patients who had thrombohemorrhagic disorders before admission to the hospital
Pregnant women
Patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital

Trial locations and contacts

1 site in 1 country.

Russia1 site

Clinic №1 of Volgograd State Medical University
Volgograd, 400079

Other trials in Russia

About this study

Official title: Surgical and Anesthesiological-resuscitation Aspects of Therapeutic Tactics for Thrombotic and Hemorrhagic Complications in Patients With the New Coronavirus Infection COVID-19

The nature of the planned study:

The topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with COVID-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes.

It is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with COVID-19 during the pandemic (8 cities).

As a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with COVID-19.

The proposed study will be multicenter, cohort, retrospective.

The purpose of the study:

Improvement of treatment results in COVID-19 patients with thrombotic or hemorrhagic complications

Scientific novelty:

For the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with COVID-19.

For the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of COVID-19.

Conditions: COVID-19 (Coronavirus Disease 2019)
Being tested: Prevention algorithm
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prevention algorithmDiagnostic test
Development of an algorithm for the prevention of thrombohemorrhagic complications

Study groups in NCT06223945
Study group	Role	What they receive
Thrombotic and hemorrhagic complications of COVID-19	Active comparator	Not described Receives: Diagnostic Test: Prevention algorithm
Prevention of thrombohemorrhagic complications in COVID-19	Active comparator	Not described Receives: Diagnostic Test: Prevention algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

development of an algorithm for the prevention of thrombohemorrhagic complications of COVID-19
It is planned to perform a multicenter cohort retrospective study with an expanded analysis of the clinical features of the course, the results of surgical treatment, intensive care, anesthesiological and resuscitation benefits in patients with COVID-19, the course of which was complicated by thrombotic and hemorrhagic complications, including internal and external bleeding from the hollow organs of the abdominal cavity, retroperitoneal space and chest. The material for the study will be formed by combining data from several large clinics, on the basis of which infectious diseases hospitals with a concentration of surgical patients have been deployed. Based on the cumulative assessment of the results obtained, new and improved previously developed surgical and anesthetic-resuscitation algorithms for diagnosis, surgical tactics, intensive care in patients with COVID-19 with thrombotic and hemorrhagic complications in need of surgical and resuscitation procedures will be proposed.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202412 Jan 2029

First posted25 Jan 2024
Study start12 Jan 2024
Primary completion12 Jan 2029 (estimated)
Study completion12 Jan 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19 (Coronavirus Disease 2019)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 1 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06223945
Sponsor's protocol ID: 12/2024/01/12
Status last verified: Jan 2024
First submitted: 22 Jan 2024
Last updated: 25 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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